A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
NCT ID: NCT00710684
Last Updated: 2017-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
682 participants
INTERVENTIONAL
2008-07-01
2010-11-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DONEPEZIL + SB-742457 15 MG
SB-742457 - 15mg added to existing donepezil treatment
SB-742457 15mg
SB-742457 - 15mg added to existing donepezil treatment
donepezil 5-10mg
existing donepezil treatment
DONEPEZIL + PLACEBO
Placebo added to existing donepezil
Placebo
Placebo added to existing donepezil
donepezil 5-10mg
existing donepezil treatment
DONEPEZIL + SB-742457 35 MG
SB-742457 - 35mg added to existing donepezil
SB-742457 35mg
SB-742457 - 35mg added to existing donepezil
donepezil 5-10mg
existing donepezil treatment
Interventions
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SB-742457 15mg
SB-742457 - 15mg added to existing donepezil treatment
SB-742457 35mg
SB-742457 - 35mg added to existing donepezil
Placebo
Placebo added to existing donepezil
donepezil 5-10mg
existing donepezil treatment
Eligibility Criteria
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Inclusion Criteria
* Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
* Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
* Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control.
* Subjects must have adequate blood pressure and laboratory values.
Exclusion Criteria
* Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.
50 Years
85 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Litchfield Park, Arizona, United States
GSK Investigational Site
Fresno, California, United States
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Rancho Mirage, California, United States
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San Francisco, California, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Paterson, New Jersey, United States
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Syracuse, New York, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Tulsa, Oklahoma, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Bennington, Vermont, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Santa Fe, , Argentina
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Kogarah, New South Wales, Australia
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Herston, Queensland, Australia
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Woodville, South Australia, Australia
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Ballarat, Victoria, Australia
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Heidelberg West, Victoria, Australia
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Kew, Victoria, Australia
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Nedlands, Western Australia, Australia
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Saint John, New Brunswick, Canada
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Kentville, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Québec, , Canada
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Viña del Mar, Región de Valparaíso, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, Región Metro de Santiago, Chile
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Santiago, , Chile
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Mělník, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Ellwangen, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Alzenau in Unterfranken, Bavaria, Germany
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Günzburg, Bavaria, Germany
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Munich, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Unterhaching, Bavaria, Germany
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Bad Homburg, Hesse, Germany
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Achim, Lower Saxony, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Aachen, North Rhine-Westphalia, Germany
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Bad Honnef, North Rhine-Westphalia, Germany
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Bochum, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Dresden, Saxony, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Chieti Scalo, Abruzzo, Italy
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Napoli, Campania, Italy
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San Felice A Cancello - Caserta, Campania, Italy
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Cassino (FR), Lazio, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Brescia, Lombardy, Italy
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Castellanza (VA), Lombardy, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Rho, Lombardy, Italy
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Turin, Piedmont, Italy
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Lido Di Camaiore (LU), Tuscany, Italy
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Pisa, Tuscany, Italy
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Perugia, Umbria, Italy
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Valdagno (VI), Veneto, Italy
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Verona, Veneto, Italy
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Baracaldo/Vizcaya, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Castellon, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Salamanca, , Spain
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San Sebastián, , Spain
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San Vicente Del Raspeig/Alicante, , Spain
GSK Investigational Site
Valencia, , Spain
Countries
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References
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Maher-Edwards G, Watson C, Ascher J, Barnett C, Boswell D, Davies J, Fernandez M, Kurz A, Zanetti O, Safirstein B, Schronen JP, Zvartau-Hind M, Gold M. Two randomized controlled trials of SB742457 in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2015 May 7;1(1):23-36. doi: 10.1016/j.trci.2015.04.001. eCollection 2015 Jun.
Other Identifiers
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AZ3110866
Identifier Type: -
Identifier Source: org_study_id